Applied Human Factors in Medical Device Design provides an in-depth guide for engineers looking to understand the details of applying the requirements of human factors or usability in the design and development of medical devices. It is published by Academic Press/Elsevier and is available in paperback and electronically from Amazon and other online retailers.

The cadre of experts in the field of human factors that have authored this text is impressive. The numerous examples provided throughout the book are grounded in real-life experiences and provide an excellent background for the reason that this book needs to be applied to the design and development processes: avoiding device use errors.

The book is divided into seven sections that follow through the process for applying human factor concepts in the design and development of medical devices. It starts with the introduction and background to the subject, then goes through the process from discovery and input methods and applying that information to design and development. The content continues with initial evaluations (also called formative evaluation), the connection to risk management (safety-related risk), and the final validation and reporting (also known as summative evaluation). The book includes additional content to address the special cases of reusable medical devices, the presence of users with disabilities or other limitations, and medical devices that use the forward-thinking technology associated with augmented reality.

Overall, this book makes the case and provides relevant information to assist organizations in effective application of the available tools for human factors/usability to ensure patient safety and effectiveness for any product.


Although this book is accurately aimed at human factors professionals who develop medical devices, it also should provide development engineers, quality engineers, regulators, and auditors with the foundation of information for the correct application of usability/human factors. For students to benefit from this book, they should already possess general experience in the design and development of medical devices or other products. Chapter 4 outlines who should use this book and how it should be used. Unlike other texts, this one provides comprehensive references and gives practical examples to help readers identify where the requirements can be found and how they should be applied.


The book is well organized to follow a comprehensive process approach to applying human factors concepts in design and development of medical devices, with complete references to the applicable reference standards and other guidance. Although the focus is on requirements for the U.S. market, the book provides users with worldwide requirements and best practices to ensure human factors processes. The text provides real-world examples to understand the concepts behind human factors and apply these principles to the reader's specific design and development process and integration of human factors with risk management for medical devices.

The application of human factors and other traits associated with usability often are not well understood. The examples and practical experience provided in Applied Human Factors in Medical Device Design should help manufacturers and other medical device organizations to understand and apply them to differentiate their products in the marketplace. Any organization looking to take control of the medical device user experience should realize a high degree of success in applying the concepts outlined in this book.

Applied Human Factors in Medical Device Design


Mary Beth Privitera


Academic Press/Elsevier, 2019



About the Reviewer

Mark Swanson,is president and regulatory/quality system consultantat H&M Consulting Group, LLC, in Becker, MN, and serves on several AAMI committees, including the AAMI Human Factors Engineering Committee.